Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-25 @ 2:11 AM
Study NCT ID:
NCT00865904
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2009-03-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569105', 'term': 'lumacaftor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'otherDetails': 'PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after last dose (last dose = Day 28)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.', 'otherNumAtRisk': 18, 'otherNumAffected': 16, 'seriousNumAtRisk': 18, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.', 'otherNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.', 'otherNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.', 'otherNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Increased viscosity of bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lung hyperinflation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasal turbinate abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 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{'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tonsillar inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Post-tussive vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 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'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Cystic fibrosis lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability Based on Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'title': 'Participants With Any AE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Participants With SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after last dose (last dose = Day 28)', 'description': 'AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. An AE that started at or after initial dosing of study drug, or increased in severity after initial dosing of study drug visit is considered treatment-emergent.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.029', 'groupId': 'OG000', 'lowerLimit': '-0.0823', 'upperLimit': '0.1398'}, {'value': '-0.049', 'groupId': 'OG001', 'lowerLimit': '-0.1578', 'upperLimit': '0.0588'}, {'value': '-0.031', 'groupId': 'OG002', 'lowerLimit': '-0.1401', 'upperLimit': '0.0787'}, {'value': '0.015', 'groupId': 'OG003', 'lowerLimit': '-0.0972', 'upperLimit': '0.1263'}, {'value': '-0.009', 'groupId': 'OG004', 'lowerLimit': '-0.1146', 'upperLimit': '0.0970'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.', 'unitOfMeasure': 'liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Predicted FEV1 at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.285', 'groupId': 'OG000', 'lowerLimit': '-2.8268', 'upperLimit': '3.3973'}, {'value': '-1.637', 'groupId': 'OG001', 'lowerLimit': '-4.6836', 'upperLimit': '1.4089'}, {'value': '-0.375', 'groupId': 'OG002', 'lowerLimit': '-3.4540', 'upperLimit': '2.7046'}, {'value': '0.168', 'groupId': 'OG003', 'lowerLimit': '-2.9653', 'upperLimit': '3.3011'}, {'value': '-0.165', 'groupId': 'OG004', 'lowerLimit': '-3.1346', 'upperLimit': '2.8044'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method.', 'unitOfMeasure': 'Percent predicted of FEV1', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.085', 'spread': '0.2857', 'groupId': 'OG000'}, {'value': '-0.055', 'spread': '0.2331', 'groupId': 'OG001'}, {'value': '-0.020', 'spread': '0.3494', 'groupId': 'OG002'}, {'value': '-0.004', 'spread': '0.1916', 'groupId': 'OG003'}, {'value': '-0.023', 'spread': '0.3668', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Flow Over the Middle Half of the FVC (FEF25-75) at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.1730', 'groupId': 'OG000'}, {'value': '-0.011', 'spread': '0.3231', 'groupId': 'OG001'}, {'value': '-0.029', 'spread': '0.4373', 'groupId': 'OG002'}, {'value': '0.045', 'spread': '0.2702', 'groupId': 'OG003'}, {'value': '-0.052', 'spread': '0.3558', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'FEF25-75 is total volume of air exhaled from the lungs over the middle half of the FVC test, expressed as liters per second (L/sec).', 'unitOfMeasure': 'liters per second (L/sec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sweat Chloride at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000', 'lowerLimit': '-3.493', 'upperLimit': '5.166'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '-3.308', 'upperLimit': '5.173'}, {'value': '-3.77', 'groupId': 'OG002', 'lowerLimit': '-7.966', 'upperLimit': '0.416'}, {'value': '-5.29', 'groupId': 'OG003', 'lowerLimit': '-9.618', 'upperLimit': '-0.963'}, {'value': '-7.38', 'groupId': 'OG004', 'lowerLimit': '-11.590', 'upperLimit': '-3.166'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Sweat samples were collected using an approved Macroduct (Wescor) collection device. A volume of greater than or equal to (\\>=) 15 microliter was required for determination of sweat chloride.', 'unitOfMeasure': 'millimole per liter (mmol/L)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Nasal Potential Difference (NPD) of Zero Chloride Plus Isoproterenol Response at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.017', 'groupId': 'OG000', 'lowerLimit': '-3.2979', 'upperLimit': '1.2637'}, {'value': '0.832', 'groupId': 'OG001', 'lowerLimit': '-1.1302', 'upperLimit': '2.7943'}, {'value': '0.142', 'groupId': 'OG002', 'lowerLimit': '-2.0369', 'upperLimit': '2.3208'}, {'value': '1.382', 'groupId': 'OG003', 'lowerLimit': '-0.9853', 'upperLimit': '3.7491'}, {'value': '1.583', 'groupId': 'OG004', 'lowerLimit': '-0.6952', 'upperLimit': '3.8612'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Nasal potential difference (NPD) provides a direct and sensitive evaluation of sodium and chloride transport in secretory epithelial cells via assessment of transepithelial bioelectric properties. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol is reported.\n\nNPDs were performed according to Cystic Fibrosis Foundation Therapeutics Development Network (CFFT TDN) Standard Operating Procedure (SOP) 528.00 "Standardization of Measurement of Nasal Membrane Transepithelial Potential Difference (NPD) - electronic data capture (EDC) and Perfusion or Perfusion-Free Probe".', 'unitOfMeasure': 'millivolts (mV)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Domain Scores at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'title': 'Body', 'categories': [{'measurements': [{'value': '-1.341', 'groupId': 'OG000', 'lowerLimit': '-6.4183', 'upperLimit': '3.7370'}, {'value': '-0.206', 'groupId': 'OG001', 'lowerLimit': '-5.2276', 'upperLimit': '4.8151'}, {'value': '-1.626', 'groupId': 'OG002', 'lowerLimit': '-6.6796', 'upperLimit': '3.4276'}, {'value': '2.611', 'groupId': 'OG003', 'lowerLimit': '-2.5525', 'upperLimit': '7.7746'}, {'value': '0.058', 'groupId': 'OG004', 'lowerLimit': '-4.8954', 'upperLimit': '5.0123'}]}]}, {'title': 'Digestion', 'categories': [{'measurements': [{'value': '4.620', 'groupId': 'OG000', 'lowerLimit': '-0.2530', 'upperLimit': '9.4935'}, {'value': '2.284', 'groupId': 'OG001', 'lowerLimit': '-2.4928', 'upperLimit': '7.0605'}, {'value': '-0.719', 'groupId': 'OG002', 'lowerLimit': '-5.5599', 'upperLimit': '4.1216'}, {'value': '0.251', 'groupId': 'OG003', 'lowerLimit': '-4.6794', 'upperLimit': '5.1810'}, {'value': '2.578', 'groupId': 'OG004', 'lowerLimit': '-2.1027', 'upperLimit': '7.2580'}]}]}, {'title': 'Eat', 'categories': [{'measurements': [{'value': '2.110', 'groupId': 'OG000', 'lowerLimit': '-3.9925', 'upperLimit': '8.2128'}, {'value': '-3.662', 'groupId': 'OG001', 'lowerLimit': '-9.6704', 'upperLimit': '2.3463'}, {'value': '-7.269', 'groupId': 'OG002', 'lowerLimit': '-13.3216', 'upperLimit': '-1.2161'}, {'value': '3.242', 'groupId': 'OG003', 'lowerLimit': '-3.0242', 'upperLimit': '9.5087'}, {'value': '-2.576', 'groupId': 'OG004', 'lowerLimit': '-8.4313', 'upperLimit': '3.2793'}]}]}, {'title': 'Emotion', 'categories': [{'measurements': [{'value': '4.859', 'groupId': 'OG000', 'lowerLimit': '-0.4200', 'upperLimit': '10.1372'}, {'value': '-3.222', 'groupId': 'OG001', 'lowerLimit': '-8.4312', 'upperLimit': '1.9866'}, {'value': '-1.358', 'groupId': 'OG002', 'lowerLimit': '-6.5817', 'upperLimit': '3.8666'}, {'value': '3.489', 'groupId': 'OG003', 'lowerLimit': '-1.9312', 'upperLimit': '8.9087'}, {'value': '-2.624', 'groupId': 'OG004', 'lowerLimit': '-7.7058', 'upperLimit': '2.4585'}]}]}, {'title': 'Health Perceptions', 'categories': [{'measurements': [{'value': '5.034', 'groupId': 'OG000', 'lowerLimit': '-1.6041', 'upperLimit': '11.6713'}, {'value': '-2.839', 'groupId': 'OG001', 'lowerLimit': '-9.2912', 'upperLimit': '3.6131'}, {'value': '-6.967', 'groupId': 'OG002', 'lowerLimit': '-13.4203', 'upperLimit': '-0.5137'}, {'value': '-0.435', 'groupId': 'OG003', 'lowerLimit': '-7.0778', 'upperLimit': '6.2074'}, {'value': '-1.896', 'groupId': 'OG004', 'lowerLimit': '-8.3524', 'upperLimit': '4.5604'}]}]}, {'title': 'Physical', 'categories': [{'measurements': [{'value': '1.225', 'groupId': 'OG000', 'lowerLimit': '-5.3271', 'upperLimit': '7.7764'}, {'value': '-5.968', 'groupId': 'OG001', 'lowerLimit': '-12.3586', 'upperLimit': '0.4217'}, {'value': '-7.384', 'groupId': 'OG002', 'lowerLimit': '-13.8167', 'upperLimit': '-0.9508'}, {'value': '-3.464', 'groupId': 'OG003', 'lowerLimit': '-10.0613', 'upperLimit': '3.1335'}, {'value': '-0.976', 'groupId': 'OG004', 'lowerLimit': '-7.2596', 'upperLimit': '5.3067'}]}]}, {'title': 'Respiratory', 'categories': [{'measurements': [{'value': '4.534', 'groupId': 'OG000', 'lowerLimit': '-1.6158', 'upperLimit': '10.6842'}, {'value': '-5.223', 'groupId': 'OG001', 'lowerLimit': '-11.2414', 'upperLimit': '0.7956'}, {'value': '-6.324', 'groupId': 'OG002', 'lowerLimit': '-12.3453', 'upperLimit': '-0.3026'}, {'value': '-1.290', 'groupId': 'OG003', 'lowerLimit': '-7.5407', 'upperLimit': '4.9598'}, {'value': '2.215', 'groupId': 'OG004', 'lowerLimit': '-3.6610', 'upperLimit': '8.0901'}]}]}, {'title': 'Role', 'categories': [{'measurements': [{'value': '2.210', 'groupId': 'OG000', 'lowerLimit': '-3.2279', 'upperLimit': '7.6481'}, {'value': '-5.941', 'groupId': 'OG001', 'lowerLimit': '-11.3247', 'upperLimit': '-0.5577'}, {'value': '-4.599', 'groupId': 'OG002', 'lowerLimit': '-9.9912', 'upperLimit': '0.7925'}, {'value': '1.097', 'groupId': 'OG003', 'lowerLimit': '-4.4579', 'upperLimit': '6.6510'}, {'value': '-6.533', 'groupId': 'OG004', 'lowerLimit': '-11.7858', 'upperLimit': '-1.2803'}]}]}, {'title': 'Social', 'categories': [{'measurements': [{'value': '-0.554', 'groupId': 'OG000', 'lowerLimit': '-4.8235', 'upperLimit': '3.7152'}, {'value': '-0.001', 'groupId': 'OG001', 'lowerLimit': '-4.2221', 'upperLimit': '4.2200'}, {'value': '-1.013', 'groupId': 'OG002', 'lowerLimit': '-5.2372', 'upperLimit': '3.2122'}, {'value': '0.469', 'groupId': 'OG003', 'lowerLimit': '-3.8898', 'upperLimit': '4.8273'}, {'value': '-2.640', 'groupId': 'OG004', 'lowerLimit': '-6.7802', 'upperLimit': '1.5008'}]}]}, {'title': 'Treatment Burden', 'categories': [{'measurements': [{'value': '2.463', 'groupId': 'OG000', 'lowerLimit': '-3.1916', 'upperLimit': '8.1169'}, {'value': '4.185', 'groupId': 'OG001', 'lowerLimit': '-1.4220', 'upperLimit': '9.7914'}, {'value': '-5.962', 'groupId': 'OG002', 'lowerLimit': '-11.5712', 'upperLimit': '-0.3530'}, {'value': '1.421', 'groupId': 'OG003', 'lowerLimit': '-4.3528', 'upperLimit': '7.1954'}, {'value': '-0.676', 'groupId': 'OG004', 'lowerLimit': '-6.1363', 'upperLimit': '4.7843'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '-2.178', 'groupId': 'OG000', 'lowerLimit': '-8.8193', 'upperLimit': '4.4629'}, {'value': '-4.645', 'groupId': 'OG001', 'lowerLimit': '-11.1048', 'upperLimit': '1.8139'}, {'value': '-7.227', 'groupId': 'OG002', 'lowerLimit': '-13.6961', 'upperLimit': '-0.7589'}, {'value': '-1.516', 'groupId': 'OG003', 'lowerLimit': '-8.1800', 'upperLimit': '5.1472'}, {'value': '0.730', 'groupId': 'OG004', 'lowerLimit': '-5.5932', 'upperLimit': '7.0522'}]}]}, {'title': 'Weight', 'categories': [{'measurements': [{'value': '0.304', 'groupId': 'OG000', 'lowerLimit': '-9.4460', 'upperLimit': '10.0543'}, {'value': '5.410', 'groupId': 'OG001', 'lowerLimit': '-4.2393', 'upperLimit': '15.0600'}, {'value': '2.175', 'groupId': 'OG002', 'lowerLimit': '-7.5500', 'upperLimit': '11.8997'}, {'value': '8.827', 'groupId': 'OG003', 'lowerLimit': '-1.1524', 'upperLimit': '18.8063'}, {'value': '-4.186', 'groupId': 'OG004', 'lowerLimit': '-13.5956', 'upperLimit': '5.2233'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. CFQ-R domains include: Body, Digestion, Eat, Emotion, Health Perceptions, Physical, Respiratory, Role, Social, Treatment Burden, Vitality, and Weight. Individual domain score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Number of participants analyzed signifies participants evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of VX-809', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'title': 'Day 1 (n= 18, 18, 17, 19)', 'categories': [{'measurements': [{'value': '760', 'spread': '280', 'groupId': 'OG000'}, {'value': '1850', 'spread': '697', 'groupId': 'OG001'}, {'value': '2930', 'spread': '916', 'groupId': 'OG002'}, {'value': '6410', 'spread': '2550', 'groupId': 'OG003'}]}]}, {'title': 'Day 28 (n= 17, 17, 16, 18)', 'categories': [{'measurements': [{'value': '1100', 'spread': '443', 'groupId': 'OG000'}, {'value': '2660', 'spread': '1010', 'groupId': 'OG001'}, {'value': '4620', 'spread': '1840', 'groupId': 'OG002'}, {'value': '10300', 'spread': '4490', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, 24, and 30-60 hours post dose)', 'description': 'Only participants who received VX-809 were analyzed for this outcome measure.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, n = participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of VX-809', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'OG001', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'OG002', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'OG003', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'classes': [{'title': 'Day 1 (n= 18, 18, 17, 19)', 'categories': [{'measurements': [{'value': '7190', 'spread': '2190', 'groupId': 'OG000'}, {'value': '16600', 'spread': '6290', 'groupId': 'OG001'}, {'value': '29000', 'spread': '11400', 'groupId': 'OG002'}, {'value': '59500', 'spread': '26400', 'groupId': 'OG003'}]}]}, {'title': 'Day 28 (n= 17, 17, 16, 18)', 'categories': [{'measurements': [{'value': '12900', 'spread': '4920', 'groupId': 'OG000'}, {'value': '28800', 'spread': '13100', 'groupId': 'OG001'}, {'value': '54100', 'spread': '31600', 'groupId': 'OG002'}, {'value': '119000', 'spread': '73700', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post dose)', 'description': 'Only participants who received VX-809 were analyzed for this outcome measure.', 'unitOfMeasure': 'hour*nanogram per milliliter (hr*ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Here, n = participants evaluable for specified category for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'FG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 milligram (mg) capsule orally once daily for 28 days.'}, {'id': 'FG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'FG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'FG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized.', 'groupId': 'FG000', 'numSubjects': '19'}, {'comment': 'Randomized.', 'groupId': 'FG001', 'numSubjects': '18'}, {'comment': 'Randomized.', 'groupId': 'FG002', 'numSubjects': '18'}, {'comment': 'Randomized.', 'groupId': 'FG003', 'numSubjects': '18'}, {'comment': 'Randomized.', 'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed 14-day follow-up.', 'groupId': 'FG000', 'numSubjects': '17'}, {'comment': 'Completed 14-day follow-up.', 'groupId': 'FG001', 'numSubjects': '18'}, {'comment': 'Completed 14-day follow-up.', 'groupId': 'FG002', 'numSubjects': '18'}, {'comment': 'Completed 14-day follow-up.', 'groupId': 'FG003', 'numSubjects': '17'}, {'comment': 'Completed 14-day follow-up.', 'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.'}, {'id': 'BG001', 'title': 'VX-809, 25 mg', 'description': 'VX-809, 25 mg capsule orally once daily for 28 days.'}, {'id': 'BG002', 'title': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.'}, {'id': 'BG003', 'title': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.'}, {'id': 'BG004', 'title': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '9.35', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '8.98', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '8.20', 'groupId': 'BG002'}, {'value': '30.1', 'spread': '11.55', 'groupId': 'BG003'}, {'value': '26.7', 'spread': '6.82', 'groupId': 'BG004'}, {'value': '28.6', 'spread': '9.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'dispFirstSubmitDate': '2011-03-23', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-01', 'studyFirstSubmitDate': '2009-03-18', 'dispFirstSubmitQcDate': '2011-03-23', 'resultsFirstSubmitDate': '2015-08-01', 'studyFirstSubmitQcDate': '2009-03-18', 'dispFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-01', 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability Based on Adverse Events (AEs)', 'timeFrame': 'Up to 14 days after last dose (last dose = Day 28)', 'description': 'AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. Serious adverse event (SAE) (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. An AE that started at or after initial dosing of study drug, or increased in severity after initial dosing of study drug visit is considered treatment-emergent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.'}, {'measure': 'Change From Baseline in Percent Predicted FEV1 at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method.'}, {'measure': 'Change From Baseline in Forced Vital Capacity (FVC) at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.'}, {'measure': 'Change From Baseline in Forced Expiratory Flow Over the Middle Half of the FVC (FEF25-75) at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'FEF25-75 is total volume of air exhaled from the lungs over the middle half of the FVC test, expressed as liters per second (L/sec).'}, {'measure': 'Change From Baseline in Sweat Chloride at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'Sweat samples were collected using an approved Macroduct (Wescor) collection device. A volume of greater than or equal to (\\>=) 15 microliter was required for determination of sweat chloride.'}, {'measure': 'Change From Baseline in Nasal Potential Difference (NPD) of Zero Chloride Plus Isoproterenol Response at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'Nasal potential difference (NPD) provides a direct and sensitive evaluation of sodium and chloride transport in secretory epithelial cells via assessment of transepithelial bioelectric properties. NPD under conditions of zero chloride concentration perfusion solution in the presence of isoproterenol is reported.\n\nNPDs were performed according to Cystic Fibrosis Foundation Therapeutics Development Network (CFFT TDN) Standard Operating Procedure (SOP) 528.00 "Standardization of Measurement of Nasal Membrane Transepithelial Potential Difference (NPD) - electronic data capture (EDC) and Perfusion or Perfusion-Free Probe".'}, {'measure': 'Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Domain Scores at Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. CFQ-R domains include: Body, Digestion, Eat, Emotion, Health Perceptions, Physical, Respiratory, Role, Social, Treatment Burden, Vitality, and Weight. Individual domain score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of VX-809', 'timeFrame': 'Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, 24, and 30-60 hours post dose)', 'description': 'Only participants who received VX-809 were analyzed for this outcome measure.'}, {'measure': 'Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of VX-809', 'timeFrame': 'Day 1 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post-dose), Day 28 (pre dose, 0.75, 1.5, 3, 4, 6, 9, 12, and 24 hours post dose)', 'description': 'Only participants who received VX-809 were analyzed for this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['∆F508', 'F508del', 'Cystic Fibrosis Transmembrane Conductance Regulator', 'CFTR', 'Pancreatic diseases', 'Lung diseases', 'Genetic disease, inborn', 'Infant, newborn, diseases'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '37983082', 'type': 'DERIVED', 'citation': 'Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.'}, {'pmid': '33331662', 'type': 'DERIVED', 'citation': 'Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.'}, {'pmid': '21825083', 'type': 'DERIVED', 'citation': 'Clancy JP, Rowe SM, Accurso FJ, Aitken ML, Amin RS, Ashlock MA, Ballmann M, Boyle MP, Bronsveld I, Campbell PW, De Boeck K, Donaldson SH, Dorkin HL, Dunitz JM, Durie PR, Jain M, Leonard A, McCoy KS, Moss RB, Pilewski JM, Rosenbluth DB, Rubenstein RC, Schechter MS, Botfield M, Ordonez CL, Spencer-Green GT, Vernillet L, Wisseh S, Yen K, Konstan MW. Results of a phase IIa study of VX-809, an investigational CFTR corrector compound, in subjects with cystic fibrosis homozygous for the F508del-CFTR mutation. Thorax. 2012 Jan;67(1):12-8. doi: 10.1136/thoraxjnl-2011-200393. Epub 2011 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.', 'detailedDescription': 'This was a Phase 2, randomized, double-blind, placebo-controlled, multiple-dose study of orally-administered VX-809 in participants with CF who are homozygous for the specific CFTR mutation known as ∆F508 or F508del. Enrollment was planned for 90 participants at approximately 20 centers. Participants were planned to be randomized in a 4:1 ratio to receive 1 of 4 doses of VX-809 or placebo once a day for 28 days in a parallel design. Participants were outpatients during the study, except for overnight stays on Day 1 and 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of CF with ∆F508-CFTR mutation in both alleles\n* Forced expiratory volume in 1 second (FEV1) greater than or equal to (\\>=) 40 percent (%) of predicted normal for age, gender, and height\n* Weight \\>=40 kilograms (kg) and body mass index greater than or equal to 18.5 kilogram per square meter (kg/m\\^2)\n* Screening laboratory values, tests, and physical examination within acceptable ranges\n* Negative pregnancy test (for women of child-bearing potential)\n* Able and willing to follow contraceptive requirements\n* Willing to remain on a stable medication regimen for the duration of study participation\n\nExclusion Criteria:\n\n* History of any illness, or any ongoing acute illness, that could impact the safety of the study participant or may confound results of study\n* Pulmonary exacerbation or changes in therapy for pulmonary disease within 14 days before receiving the first dose of study drug\n* Impaired hepatic or renal function\n* History of organ or hematological transplant'}, 'identificationModule': {'nctId': 'NCT00865904', 'briefTitle': 'Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of VX-809 to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of VX-809 in Cystic Fibrosis Subjects Homozygous for the ∆F508-CFTR Gene Mutation', 'orgStudyIdInfo': {'id': 'VX08-809-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo matched to VX-809 capsule orally once daily for 28 days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'VX-809, 25 mg', 'description': 'VX-809, 25 milligram (mg) capsule orally once daily for 28 days.', 'interventionNames': ['Drug: VX-809']}, {'type': 'EXPERIMENTAL', 'label': 'VX-809, 50 mg', 'description': 'VX-809, 50 mg capsule orally once daily for 28 days.', 'interventionNames': ['Drug: VX-809']}, {'type': 'EXPERIMENTAL', 'label': 'VX-809, 100 mg', 'description': 'VX-809, 100 mg capsule orally once daily for 28 days.', 'interventionNames': ['Drug: VX-809']}, {'type': 'EXPERIMENTAL', 'label': 'VX-809, 200 mg', 'description': 'VX-809, 200 mg capsule orally once daily for 28 days.', 'interventionNames': ['Drug: VX-809']}], 'interventions': [{'name': 'VX-809', 'type': 'DRUG', 'description': 'Capsules', 'armGroupLabels': ['VX-809, 100 mg', 'VX-809, 200 mg', 'VX-809, 25 mg', 'VX-809, 50 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to VX-809 capsules.', 'armGroupLabels': ['Placebo']}]}, 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